• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY GLADIATOR PTA BALLOON DILATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC - GALWAY GLADIATOR PTA BALLOON DILATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number UNK722
Device Problems Balloon; Torn Material
Event Type  Injury  
Manufacturer Narrative

(b)(4). It is indicated that the device will not be returned for evaluation. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

 
Event Description

It was reported that balloon circumferential tear occurred. The target lesion was located in a vessel of the arm. Approximately two months ago, a gladiator balloon catheter was selected for use and advanced for dilation. However, during the procedure, the balloon had circumferential tear and the physician had to do a cut down to the vessel to completely retrieve the balloon from the patient's body. The procedure was not completed. No further patient complications were reported and the patient's status is fine.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGLADIATOR PTA BALLOON DILATION CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
linda leimer
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key5288703
Report Number2134265-2015-08550
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/20/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNK722
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/11/2015 Patient Sequence Number: 1
-
-